The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)

NCT04399070 | Unknown

• 1 other identifier: West China Hospital Anes
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy.

Conditions

Depression, Bipolar; Depression, Unipolar; Major Depressive Disorder; Manic-Depressive - Now Depressed

Keywords

Electroconvulsive therapy; Depression; S-ketamine

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Scale-17 scores

  the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and \<7 were normal, the higher the score means more serious disease.

  the 1 day after the last ECT

• Montgomery-Asberg Depression Rating Scale scores

  the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and \<17 were normal, the higher the score means more serious disease.

  the 1 day after the last ECT

Secondary Outcomes (18)

• Hamilton Depression Scale-17 scores

  baseline (before first ECT)

• Hamilton Depression Scale-17 scores

  one week after the first ECT

• Hamilton Depression Scale-17 scores

  one month after the last ECT

• Montgomery-Asberg Depression Rating Scale scores

  baseline (before first ECT)

• Montgomery-Asberg Depression Rating Scale scores

  one week after the first ECT

Other Outcomes (5)

• Headache

  from emergency, assessed up to 24 hours after each ECT

• Nausea and vomiting

  from emergency, assessed up to 24 hours after each ECT

• Myalgia

  from emergency, assessed up to 24 hours after each ECT

Study Arms (3)

Propofol group

PLACEBO COMPARATOR

patients were treated with propofol 1 mg/kg and saline bolus infusion before ECT

Drug: saline

Ketamine group

ACTIVE COMPARATOR

patients were treated with propofol 1 mg/kg and ketamine 0.5 mg/kg bolus infusion before ECT

Drug: ketamine

S-ketamine group

EXPERIMENTAL

patients were treated with propofol 1 mg/kg and S-ketamine 0.25 mg/kg bolus infusion before ECT

Drug: S-ketamine

Interventions

S-ketamine DRUG

The depression patients received propofol and S-ketamine before ECT

S-ketamine group

ketamine DRUG

The depression patients received propofol and ketamine before ECT

Ketamine group

saline DRUG

The depression patients received propofol and saline before ECT

Propofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status I-II
• diagnose depressive disorders with DSM-IV
• Without cognitive impairment
• Without ECT in past 6 months

You may not qualify if:

• had other comorbid psychiatric diagnoses, including schizophrenia, mania
• organic heart diseases, severe hypertension and arrhythmia
• severe hepatic and renal diseases
• severe cerebrovascular disorder or malformation, intracranial mass lesions and seizure
• glaucoma or high intraocular pressure and intra-ocular pathology
• severe haematological disease, fracture and obesity, pregnancy
• severe respiratory tract disease or difficult ventilation or incubation
• had pre-existing neurological disease or cognitive impairment
• allergy to anesthetics
• drugs abuse or alcohol addiction
• family history of malignant hyperthemia
• refuse to participate in this trial, had taken part in other clinical trial and with less education and couldn't understand the content of questionnaire

Sponsors & Collaborators

• Yan Qiu: lead

Study Sites (1)

West China Hospital of Sichuan University, Department of Anesthesiology

Chengdu, Sichuan, 610041, China

Location

Related Publications (18)

• World Health Organization. Depression and other common mental disorders: Global health estimates. Geneva: World Health Organization. 2017.

  BACKGROUND

• Ribeiro JD, Huang X, Fox KR, Franklin JC. Depression and hopelessness as risk factors for suicide ideation, attempts and death: meta-analysis of longitudinal studies. Br J Psychiatry. 2018 May;212(5):279-286. doi: 10.1192/bjp.2018.27. Epub 2018 Mar 28.

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• Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Lisanby SH; CORE/PRIDE Work Group. Right Unilateral Ultrabrief Pulse ECT in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1101-1109. doi: 10.1176/appi.ajp.2016.15081101. Epub 2016 Jul 15.

  PMID: 27418379 BACKGROUND

• Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Dooley M, Lisanby SH; CORE/PRIDE Work Group. A Novel Strategy for Continuation ECT in Geriatric Depression: Phase 2 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1110-1118. doi: 10.1176/appi.ajp.2016.16010118. Epub 2016 Jul 15.

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• Fond G, Bennabi D, Haffen E, Brunel L, Micoulaud-Franchi JA, Loundou A, Lancon C, Llorca PM, Auquier P, Boyer L. A Bayesian framework systematic review and meta-analysis of anesthetic agents effectiveness/tolerability profile in electroconvulsive therapy for major depression. Sci Rep. 2016 Jan 25;6:19847. doi: 10.1038/srep19847.

  PMID: 26806849 BACKGROUND

• Hashimoto K. Rapid-acting antidepressant ketamine, its metabolites and other candidates: A historical overview and future perspective. Psychiatry Clin Neurosci. 2019 Oct;73(10):613-627. doi: 10.1111/pcn.12902. Epub 2019 Jul 11.

  PMID: 31215725 BACKGROUND

• Li DJ, Wang FC, Chu CS, Chen TY, Tang CH, Yang WC, Chow PC, Wu CK, Tseng PT, Lin PY. Significant treatment effect of add-on ketamine anesthesia in electroconvulsive therapy in depressive patients: A meta-analysis. Eur Neuropsychopharmacol. 2017 Jan;27(1):29-41. doi: 10.1016/j.euroneuro.2016.11.008. Epub 2016 Nov 28.

  PMID: 27908572 BACKGROUND

• Erdil F, Ozgul U, Colak C, Cumurcu B, Durmus M. Effect of the Addition of Ketamine to Sevoflurane Anesthesia on Seizure Duration in Electroconvulsive Therapy. J ECT. 2015 Sep;31(3):182-5. doi: 10.1097/YCT.0000000000000225.

  PMID: 25719444 BACKGROUND

• Kishimoto T, Chawla JM, Hagi K, Zarate CA, Kane JM, Bauer M, Correll CU. Single-dose infusion ketamine and non-ketamine N-methyl-d-aspartate receptor antagonists for unipolar and bipolar depression: a meta-analysis of efficacy, safety and time trajectories. Psychol Med. 2016 May;46(7):1459-72. doi: 10.1017/S0033291716000064. Epub 2016 Feb 12.

  PMID: 26867988 BACKGROUND

• Wilkinson ST, Ballard ED, Bloch MH, Mathew SJ, Murrough JW, Feder A, Sos P, Wang G, Zarate CA Jr, Sanacora G. The Effect of a Single Dose of Intravenous Ketamine on Suicidal Ideation: A Systematic Review and Individual Participant Data Meta-Analysis. Am J Psychiatry. 2018 Feb 1;175(2):150-158. doi: 10.1176/appi.ajp.2017.17040472. Epub 2017 Oct 3.

  PMID: 28969441 BACKGROUND

• Zhang K, Hashimoto K. An update on ketamine and its two enantiomers as rapid-acting antidepressants. Expert Rev Neurother. 2019 Jan;19(1):83-92. doi: 10.1080/14737175.2019.1554434. Epub 2018 Dec 4.

  PMID: 30513009 BACKGROUND

• Sackeim HA. Modern Electroconvulsive Therapy: Vastly Improved yet Greatly Underused. JAMA Psychiatry. 2017 Aug 1;74(8):779-780. doi: 10.1001/jamapsychiatry.2017.1670. No abstract available.

  PMID: 28658461 BACKGROUND

• Carspecken CW, Borisovskaya A, Lan ST, Heller K, Buchholz J, Ruskin D, Rozet I. Ketamine Anesthesia Does Not Improve Depression Scores in Electroconvulsive Therapy: A Randomized Clinical Trial. J Neurosurg Anesthesiol. 2018 Oct;30(4):305-313. doi: 10.1097/ANA.0000000000000511.

  PMID: 29847468 BACKGROUND

• Zheng W, Li XH, Zhu XM, Cai DB, Yang XH, Ungvari GS, Ng CH, Ning YP, Hu YD, He SH, Wang G, Xiang YT. Adjunctive ketamine and electroconvulsive therapy for major depressive disorder: A meta-analysis of randomized controlled trials. J Affect Disord. 2019 May 1;250:123-131. doi: 10.1016/j.jad.2019.02.044. Epub 2019 Feb 18.

  PMID: 30852364 BACKGROUND

• Daly EJ, Singh JB, Fedgchin M, Cooper K, Lim P, Shelton RC, Thase ME, Winokur A, Van Nueten L, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):139-148. doi: 10.1001/jamapsychiatry.2017.3739.

  PMID: 29282469 BACKGROUND

• Popova V, Daly EJ, Trivedi M, Cooper K, Lane R, Lim P, Mazzucco C, Hough D, Thase ME, Shelton RC, Molero P, Vieta E, Bajbouj M, Manji H, Drevets WC, Singh JB. Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study. Am J Psychiatry. 2019 Jun 1;176(6):428-438. doi: 10.1176/appi.ajp.2019.19020172. Epub 2019 May 21.

  PMID: 31109201 BACKGROUND

• Canuso CM, Singh JB, Fedgchin M, Alphs L, Lane R, Lim P, Pinter C, Hough D, Sanacora G, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Am J Psychiatry. 2018 Jul 1;175(7):620-630. doi: 10.1176/appi.ajp.2018.17060720. Epub 2018 Apr 16.

  PMID: 29656663 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder; Depressive Disorder, Major; Depression

Interventions

Esketamine; Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Guizhi Du, Doctor

  West China Hospital of Sichuan University, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Qiu, Doctor

CONTACT

+8618980606269; qiuyan_mz@126.com

Guizhi Du, Doctor

CONTACT

+8618980602213; du_guizhi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 22, 2020
• Study Start: August 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 31, 2021
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)